LEVETIRACETAM GENERIC HEALTH levetiracetam 1000mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Levetiracetam

Available from:

Torrent Australasia Pty Ltd

INN (International Name):

Levetiracetam

Patient Information leaflet

1
LEVETIRACETAM GENERIC HEALTH
Levetiracetam Tablets
Consumer Medicine Information
What is in this leaflet
Please read this leaflet carefully
before you take this medicine.
This
leaflet
answers
some
common
questions
about
levetiracetam. It does not contain
all of the available information.
It
does
not
take
the
place
of
talking
to
your
doctor
or
pharmacist.
All medicines have risks and
benefits.
Sometimes
new
risks
are found even when a medicine
has been used for many years.
Your
doctor
has
weighed
the
expected benefits of you taking
levetiracetam
against
the
risks
this
medicine
could
have
for
you.
If you have any concerns about
taking this medicine, ask your
doctor or pharmacist.
Keep
this
leaflet
with
the
medicine.
You may need to read it again.
What is Levetiracetam
Generic Health
used for
Levetiracetam Generic Health is
used for the control of epilepsy
in adults and children.
Epilepsy is a condition where
you have repeated seizures (fits).
There are many different types
of seizures, ranging from mild to
severe.
Levetiracetam
(the
active
ingredient
in
Levetiracetam
Generic Health/) belongs to a
group
of
medicines
called
antiepileptics.
These medicines are thought to
work
by
controlling
brain
chemicals which send signals to
nerves so that seizures do not
happen.
Levetiracetam
may
be
used
alone,
or
in
combination
with
other
medicines,
to
treat
your
condition.
Your
doctor
may
prescribe
levetiracetam in addition to your
current therapy.
Ask your doctor if you have
any
questions
about
why
levetiracetam
has
been
prescribed for you.
Levetiracetam is not known to
be addictive.
This medicine is available only
with a doctor's prescription.
The safety and effectiveness of
Levetiracetam has not been
established in patients less than 4
years of age.
Before you take
Levetiracetam Generic
Health
Do not take if you have an
allergy to:
•
any of the ingredients listed at
the end of this leaflet
Symptoms of an allergic reaction
to levetiracetam may include:
•
shortness of breath, wheezing
or difficulty breathing
•
swelling

Summary of Product characteristics

PRODUCT INFORMATION
LEVETIRACETAM GENERIC HEALTH
Levetiracetam Tablets
Name of the Medicine
Levetiracetam
Chemical name: (S)-2-(2-oxopyrrolidin-1-yl)butanamide.
Molecular Formula: C
8
H
14
N
2
O
2
Molecular weight: 170.2
CAS: 102767-28-2.
Description
Levetiracetam is a pure enantiomer. It is a white to off white powder
with a faint odour and a bitter
taste. It is very soluble in water (104 g/100 mL). It is freely
soluble in chloroform (65.3 mg/100 mL)
and in methanol (53.6 g/100mL), soluble in ethanol (16.5 g/100 mL),
sparingly soluble in
acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane.
Pharmacology
The precise mechanism of action by which levetiracetam induces seizure
protection is unknown,
but appears unrelated to the mechanisms of current antiepileptic
drugs. In vitro and in vivo
experiments suggest that levetiracetam does not alter basic cell
characteristics and normal
neurotransmission.
In vitro studies show that levetiracetam affects intraneuronal Ca
2+
levels by partial inhibition of N
type Ca
2+
currents and by reducing the release of Ca
2+
from intraneuronal stores. In addition, it
partially reverses the reductions in GABA and glycine gated currents
induced by zinc and beta-
carbolines. Furthermore, levetiracetam has been shown in in vitro
studies to bind to a specific site
in rodent brain tissue. This binding site is the synaptic vesicle
protein 2A, believed to be involved in
vesicle fusion and neurotransmitter exocytosis. Levetiracetam and
related analogues show a rank
order of affinity for binding to the synaptic vesicle protein 2A which
correlates with the potency of
their antiseizure protection in the mouse audiogenic model of
epilepsy.
This finding suggests that
the interaction between levetiracetam and the synaptic vesicle protein
2A seems to contribute to
the antiepileptic mechanism of action of the drug.
Pharmacodynamics in animals.
Levetiracetam is not active in the classical screening models for
anticonvulsants, however it induces potent protection in a broad range
of animal